July 14, 2015 RULE ANALYSIS Introduction: THE AMENDMENTS ARE SUBMITTED TO THE BOARD FOR CONSIDERATION AS A PROPOSED RULE Short Title: Notifications Rule Numbers: §291.3 Statutory Authority: Texas Pharmacy Act, Chapter 551-569, Occupations Code: (1) Section 551.002 specifies that the purpose of the Act is to protect the public through the effective control and regulation of the practice of pharmacy; and (2) Section 554.051 gives the Board the authority to adopt rules for the proper administration and enforcement of the Act. Purpose: The amendments, if adopted, implement provisions of SB 460 requiring pharmacies to notify the board at least 30 days prior to changing location and allow pharmacies to notify consumers regarding complaints against the practice of pharmacy in an electronic messaging system; update the change of pharmacist employment requirements; and include Veterinary-Verified Pharmacy Practice Sites (Vet-VIPPS) as being in compliance with internet notifications.
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July 14, 2015
RULE ANALYSIS Introduction: THE AMENDMENTS ARE SUBMITTED TO THE BOARD FOR
CONSIDERATION AS A PROPOSED RULE Short Title: Notifications Rule Numbers: §291.3
Statutory Authority: Texas Pharmacy Act, Chapter 551-569, Occupations Code: (1) Section 551.002 specifies that the purpose of the Act is to
protect the public through the effective control and regulation of the practice of pharmacy; and
(2) Section 554.051 gives the Board the authority to adopt rules for the proper administration and enforcement of the Act.
Purpose: The amendments, if adopted, implement provisions of SB 460
requiring pharmacies to notify the board at least 30 days prior to changing location and allow pharmacies to notify consumers regarding complaints against the practice of pharmacy in an electronic messaging system; update the change of pharmacist employment requirements; and include Veterinary-Verified Pharmacy Practice Sites (Vet-VIPPS) as being in compliance with internet notifications.
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TITLE 22 EXAMINING BOARDS 1 PART 15 TEXAS STATE BOARD OF PHARMACY 2 CHAPTER 291 PHARMACIES 3 SUBCHAPTER A ALL CLASSES OF PHARMACIES 4 5 §291.3 Required Notifications 6 7 (a) Change of Location and/or Name. 8 9 (1) When a pharmacy changes location and/or name, the following is applicable. 10 11 (A) A new completed pharmacy application containing the information outlined in §291.1 of 12 this title (relating to Pharmacy License Application), must be filed with the board not later than 13 30 days before the date [within 10 days] of the change of location of the pharmacy. 14 15 (B) The previously issued license must be returned to the board office. 16 17 (C) An amended license reflecting the new location and/or name of the pharmacy will be 18 issued by the board; and 19 20 (D) A fee as specified in §291.6 of this title (relating to Pharmacy License Fees) will be 21 charged for issuance of the amended license. 22 23 (2) At least 14 days prior to the change of location of a pharmacy that dispenses prescription 24 drug orders, the pharmacist-in-charge shall post a sign in a conspicuous place indicating that 25 the pharmacy is changing locations. Such sign shall be in the front of the prescription 26 department and at all public entrance doors to the pharmacy and shall indicate the date the 27 pharmacy is changing locations. 28 29 (3) Disasters, accidents, and emergencies which require the pharmacy to change location shall 30 be immediately reported to the board. If a pharmacy changes location suddenly due to 31 disasters, accidents, or other emergency circumstances and the pharmacist-in-charge cannot 32 provide notification 14 days prior to the change of location, the pharmacist-in-charge shall 33 comply with the provisions of paragraph (2) of this subsection as far in advance of the change of 34 location as allowed by the circumstances. 35 36 (b) Change of Managing Officers. 37 38 (1) The owner of a pharmacy shall notify the board in writing within 10 days of a change of any 39 managing officer of a partnership or corporation which owns a pharmacy. The written 40 notification shall include the effective date of such change and the following information for all 41 managing officers: 42 43 (A) name and title; 44 45 (B) home address and telephone number; 46 47 (C) date of birth; 48 49 (D) a copy of social security card or other official document showing the social security 50 number as approved by the board; however, if an individual is unable to obtain a social security 51
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number, an individual taxpayer identification number may be provided in lieu of a social security 52 number along with documentation indicating why the individual is unable to obtain a social 53 security number; and 54 55 (E) a copy of current driver's license, state issued photo identification card, or passport. 56 57 (2) For purposes of this subsection, managing officers are defined as the top four executive 58 officers, including the corporate officer in charge of pharmacy operations, who are designated 59 by the partnership or corporation to be jointly responsible for the legal operation of the 60 pharmacy. 61 62 (c) Change of Ownership. 63 64 (1) When a pharmacy changes ownership, a new pharmacy application must be filed with the 65 board following the procedures as specified in §291.1 of this title (relating to Pharmacy License 66 Application). In addition, a copy of the purchase contract or mutual agreement between the 67 buyer and seller must be submitted. 68 69 (2) The license issued to the previous owner must be returned to the board. 70 71 (3) A fee as specified in §291.6 of this title will be charged for issuance of a new license. 72 73 (d) Change of Pharmacist Employment. 74 75 (1) Change of pharmacist employed in a pharmacy. When a change in pharmacist employment 76 occurs, the pharmacist shall report such change in writing to the board within 10 days. 77 78 (2) Change of pharmacist-in-charge of a pharmacy. 79 80 [(A) On the date of change of the pharmacist-in-charge of a Class A, Class A-S, Class C, 81 Class C-S, or Class F pharmacy, an inventory specified in §291.17 of this title (relating to 82 Inventory Requirements) shall be taken.] 83 84 [(B) This inventory shall constitute, for the purpose of this section, the closing inventory of the 85 departing pharmacist-in-charge and the beginning inventory of the incoming pharmacist-in-86 charge.] 87 88 [(C) If the departing and the incoming pharmacists-in-charge are unable to conduct the 89 inventory together, a closing inventory shall be conducted by the departing pharmacist-in-90 charge and a new and separate beginning inventory shall be conducted by the incoming 91 pharmacist-in-charge.] 92 93 [(D)] The incoming pharmacist-in-charge shall be responsible for notifying the board within 10 94 days in writing on a form provided by the board that a change of pharmacist-in-charge has 95 occurred. The notification shall include the following: 96 97 (A) [(i)] the name and license number of the departing pharmacist-in-charge; 98 99 (B) [(ii)] the name and license number of the incoming pharmacist-in-charge; 100 101 (C) [(iii)] the date the incoming pharmacist-in-charge became the pharmacist-in-charge; and 102
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103 (D) [(iv)] a statement signed by the incoming pharmacist-in-charge attesting that: 104 105 (i) [(I)] an inventory, as specified in §291.17 of this title (relating to Inventory 106 Requirements), has been conducted by the departing and incoming pharmacists-in-charge; if 107 the inventory was not taken by both pharmacists, the statement shall provide an explanation; 108 and 109 110 (ii) [(II)] the incoming pharmacist-in-charge has read and understands the laws and rules 111 relating to this class of pharmacy. 112 113 (e) Notification of Theft or Loss of a Controlled Substance or a Dangerous Drug. 114 115 (1) Controlled substances. For the purposes of the Act, §562.106, the theft or significant loss of 116 any controlled substance by a pharmacy shall be reported in writing to the board immediately on 117 discovery of such theft or loss. A pharmacy shall be in compliance with this subsection by 118 submitting to the board a copy of the Drug Enforcement Administration (DEA) report of theft or 119 loss of controlled substances, DEA Form 106, or by submitting a list of all controlled substances 120 stolen or lost. 121 122 (2) Dangerous drugs. A pharmacy shall report in writing to the board immediately on discovery 123 the theft or significant loss of any dangerous drug by submitting a list of the name and quantity 124 of all dangerous drugs stolen or lost. 125 126 (f) Fire or Other Disaster. If a pharmacy experiences a fire or other disaster, the following 127 requirements are applicable. 128 129 (1) Responsibilities of the pharmacist-in-charge. 130 131 (A) The pharmacist-in-charge shall be responsible for reporting the date of the fire or other 132 disaster which may affect the strength, purity, or labeling of drugs, medications, devices, or 133 other materials used in the diagnosis or the treatment of the injury, illness, and disease; such 134 notification shall be immediately reported to the board, but in no event shall exceed 10 days 135 from the date of the disaster. 136 137 (B) The pharmacist-in-charge or designated agent shall comply with the following procedures. 138 139 (i) If controlled substances, dangerous drugs, or Drug Enforcement Administration (DEA) 140 order forms are lost or destroyed in the disaster, the pharmacy shall: 141 142 (I) notify the DEA, Department of Public Safety (DPS), and Texas State Board of Pharmacy 143 (board) of the loss of the controlled substances or order forms. A pharmacy shall be in 144 compliance with this section by submitting to each of these agencies a copy of the DEA's report 145 of theft or loss of controlled substances, DEA Form-106, immediately on discovery of the loss; 146 and 147 148 (II) notify the board in writing of the loss of the dangerous drugs by submitting a list of the 149 dangerous drugs lost. 150 151 (ii) If the extent of the loss of controlled substances or dangerous drugs is not able to be 152 determined, the pharmacy shall: 153
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154 (I) take a new, complete inventory of all remaining drugs specified in §291.17(c) of this title 155 (relating to Inventory Requirements); 156 157 (II) submit to DEA and DPS a statement attesting that the loss of controlled substances is 158 indeterminable and that a new, complete inventory of all remaining controlled substances was 159 conducted and state the date of such inventory; and 160 161 (III) submit to the board a statement attesting that the loss of controlled substances and 162 dangerous drugs is indeterminable and that a new, complete inventory of the drugs specified in 163 §291.17(c) of this title was conducted and state the date of such inventory. 164 165 (C) If the pharmacy changes to a new, permanent location, the pharmacist-in-charge shall 166 comply with subsection (a) of this section. 167 168 (D) If the pharmacy moves to a temporary location, the pharmacist shall comply with 169 subsection (a) of this section. If the pharmacy returns to the original location, the pharmacist-in-170 charge shall again comply with subsection (a) of this section. 171 172 (E) If the pharmacy closes due to fire or other disaster, the pharmacy may not be closed for 173 longer than 90 days as specified in §291.11 of this title (relating to Operation of a Pharmacy). 174 175 (F) If the pharmacy discontinues business (ceases to operate as a pharmacy), the 176 pharmacist-in-charge shall comply with §291.5 of this title (relating to Closing a Pharmacy). 177 178 (G) The pharmacist-in-charge shall maintain copies of all inventories, reports, or notifications 179 required by this section for a period of two years. 180 181 (2) Drug stock. 182 183 (A) Any drug which has been exposed to excessive heat, smoke, or other conditions which 184 may have caused deterioration shall not be dispensed. 185 186 (B) Any potentially adulterated or damaged drug shall only be sold, transferred, or otherwise 187 distributed pursuant to the provisions of the Texas Food Drug and Cosmetics Act (Chapter 431, 188 Health and Safety Code) administered by the Bureau of Food and Drug Safety of the Texas 189 Department of State Health Services. 190 191 (g) Notification to Consumers. 192 193 (1) Pharmacy. 194 195 (A) Every licensed pharmacy shall provide notification to consumers of the name, mailing 196 address, Internet site address, and telephone number of the board for the purpose of directing 197 complaints concerning the practice of pharmacy to the board. Such notification shall be provided 198 as follows. 199 200 (i) If the pharmacy serves walk-in customers, the pharmacy shall either: 201 202 (I) post in a prominent place that is in clear public view where prescription drugs are 203 dispensed: 204
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205 (-a-) a sign [furnished by the board] which notifies the consumer that complaints 206 concerning the practice of pharmacy may be filed with the board and list the board's name, 207 mailing address, Internet site address, telephone number [of the board], and [if applicable] a toll-208 free telephone number for filing complaints; or 209 210 (-b-) an electronic messaging system in a type size no smaller than ten-point Times 211 Roman which notifies the consumer that complaints concerning the practice of 212 pharmacy may be filed with the board and list the board’s name, mailing address, 213 Internet site address, telephone number, and a toll-free number for filing complaints; or 214 215 (II) provide with each dispensed prescription a written notification in a type size no smaller 216 than ten-point Times Roman which states the following: "Complaints concerning the practice of 217 pharmacy may be filed with the Texas State Board of Pharmacy at: (list the mailing address, 218 Internet site address, telephone number of the board, and if applicable a toll-free telephone 219 number for filing complaints)." 220 221 (ii) If the prescription drug order is delivered to patients at their residence or other designated 222 location, the pharmacy shall provide with each dispensed prescription a written notification in 223 type size no smaller than ten-point Times Roman which states the following: "Complaints 224 concerning the practice of pharmacy may be filed with the Texas State Board of Pharmacy at: 225 (list the mailing address, Internet site address, telephone number [of the board], and [if 226 applicable] a toll-free telephone number for filing complaints)." If multiple prescriptions are 227 delivered to the same location, only one such notice shall be required. 228 229 (iii) The provisions of this subsection do not apply to prescriptions for patients in facilities 230 where drugs are administered to patients by a person required to do so by the laws of the state 231 (i.e., nursing homes). 232 233 (B) A pharmacy that maintains a generally accessible site on the Internet that is located in 234 Texas or sells or distributes drugs through this site to residents of this state shall post the 235 following information on the pharmacy's initial home page and on the page where a sale of 236 prescription drugs occurs. 237 238 (i) Information on the ownership of the pharmacy, to include at a minimum, the: 239 240 (I) owner's name or if the owner is a partnership or corporation, the partnership's or 241 corporation's name and the name of the chief operating officer; 242 243 (II) owner's address; 244 245 (III) owner's telephone number; and 246 247 (IV) year the owner began operating pharmacies in the United States. 248 249 (ii) The Internet address and toll free telephone number that a consumer may use to: 250 251 (I) report medication/device problems to the pharmacy; and 252 253 (II) report business compliance problems. 254 255
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(iii) Information about each pharmacy that dispenses prescriptions for this site, to include at 256 a minimum, the: 257 258 (I) pharmacy's name, address, and telephone number; 259 260 (II) name of the pharmacist responsible for operation of the pharmacy; 261 262 (III) Texas pharmacy license number for the pharmacy and a link to the Internet site 263 maintained by the Texas State Board of Pharmacy; and 264 265 (IV) the names of all other states in which the pharmacy is licensed, the license number in 266 that state, and a link to the Internet site of the entity that regulates pharmacies in that state, if 267 available. 268 269 (C) A pharmacy whose Internet site has been awarded a Verified Internet Pharmacy Practice 270 Sites (VIPPS) or Veterinary-Verified Internet Pharmacy Practice Sites (Vet-VIPPS) 271 accreditation [certification] by the National Association of Boards of Pharmacy shall be in 272 compliance with subparagraph (B) of this paragraph by displaying the VIPPS or Vet-VIPPS seal 273 on the pharmacy internet site. 274 275 (2) Texas State Board of Pharmacy. On or before January 1, 2005, the board shall establish a 276 pharmacy profile system as specified in §2054.2606, Government Code. 277 278 (A) The board shall make the pharmacy profiles available to the public on the agency's 279 Internet site. 280 281 (B) A pharmacy profile shall contain at least the following information: 282 283 (i) name, address, and telephone number of the pharmacy; 284 285 (ii) pharmacy license number, licensure status, and expiration date of the license; 286 287 (iii) the class and type of the pharmacy; 288 289 (iv) ownership information for the pharmacy; 290 291 (v) names and license numbers of all pharmacists working at the pharmacy; 292 293 (vi) whether the pharmacy has had prior disciplinary action by the board; 294 295 (vii) whether the pharmacy's consumer service areas are accessible to disabled persons, as 296 defined by law; 297 298 (viii) the type of language translating services, including translating services for persons with 299 impairment of hearing, that the pharmacy provides for consumers; and 300 301 (ix) insurance information including whether the pharmacy participates in the state Medicaid 302 program. 303 304 (C) The board shall gather this information on initial licensing and update the information in 305 conjunction with the license renewal for the pharmacy. 306
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307 (h) Notification of Licensees or Registrants Obtaining Controlled Substances or Dangerous 308 Drugs by Forged Prescriptions. If a licensee or registrant obtains controlled substances or 309 dangerous drugs from a pharmacy by means of a forged prescription, the pharmacy shall report 310 in writing to the board immediately on discovery of such forgery. A pharmacy shall be in 311 compliance with this subsection by submitting to the board the following: 312 313 (1) name of licensee or registrant obtaining controlled substances or dangerous drugs by 314 forged prescription; 315 316 (2) date(s) of forged prescription(s); 317 318 (3) name(s) and amount(s) of drug(s); and 319 320 (4) copies of forged prescriptions. 321
S.B.ANo.A460
AN ACT
relating to the licensing and regulation of pharmacists and
pharmacies.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTIONA1.AASection 483.047, Health and Safety Code, is
amended by amending Subsection (a) and adding Subsections (b-1) and
(b-2) to read as follows:
(a)AAExcept as authorized by Subsections [Subsection] (b)
and (b-1), a pharmacist commits an offense if the pharmacist
refills a prescription unless:
(1)AAthe prescription contains an authorization by the
practitioner for the refilling of the prescription, and the
pharmacist refills the prescription in the manner provided by the
authorization; or
(2)AAat the time of refilling the prescription, the
pharmacist is authorized to do so by the practitioner who issued the
prescription.
(b-1)AANotwithstanding Subsection (b), in the event of a
natural or manmade disaster, a pharmacist may dispense not more
than a 30-day supply of a dangerous drug without the authorization
of the prescribing practitioner if:
(1)AAfailure to refill the prescription might result in
an interruption of a therapeutic regimen or create patient